NCT01989910

Compare the Efficacy and Safety of Raltegravir Versus Efavirenz Combination Therapy in Treatment-naïve HIV-1 Patients

An Open Label, Randomized, Parallel Design Estimation Pilot Study to Compare the Efficacy and Safety of Raltegravir-based Versus Efavirenz-based Combination Therapy in Treatment-naïve Patients With HIV-1 Infection

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 107 (actual)
• Sponsor: Taipei Veterans General Hospital, Taiwan · Other Government
• Sex: All
• Age: 20 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

A pilot study to compare the efficacy and safety of raltegravir-based versus efavirenz-based combination therapy in treatment-naïve patients with HIV-1 infection.

Detailed description

A single-center, prospective, randomized, open label, parallel study to compare the efficacy and safety of raltegravir-based versus efavirenz-based plus optimal nucleoside reverse-transcriptase inhibitors(NRTIs) backbone combination therapy in treatment-naïve patients with HIV-1 infection.

Conditions

• HIV-1 Infection

Interventions

Type	Name	Description
DRUG	Raltegravir	Raltegravir 400mg oral twice daily
DRUG	Efavirenz	Efavirenz 600mg oral at bedtime

Timeline

• Start date: 2013-09-01
• Primary completion: 2015-12-01
• Completion: 2017-12-01
• First posted: 2013-11-21
• Last updated: 2019-02-25
• Results posted: 2019-02-25

Locations

1 site across 1 country: Taiwan